Bone Level Healing Abutment 4035-3HA

GUDID D78540353HA0

4mm Healing Abutment 4mm Diameter 3mm Height

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD78540353HA0
NIH Device Record Key13a6955e-79e4-4041-b56b-e817bfa08441
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level Healing Abutment
Version Model Number4mm Healing Abutment
Catalog Number4035-3HA
Company DUNS094146123
Company NameOCO BIOMEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD78540353HA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


[D78540353HA0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-13

On-Brand Devices [Bone Level Healing Abutment]

D78560575HA06mm Healing Abutment 6mm Diameter 5mm Height
D78560573HA06mm Healing Abutment 6mm Diameter 3mm Height
D78550455HA05mm Healing Abutment 5mm Diameter 5mm Height
D78550453HA05mm Healing Abutment 5mm Diameter 3mm Height
D78540355HA04mm Healing Abutment 4mm Diameter 5mm Height
D78540353HA04mm Healing Abutment 4mm Diameter 3mm Height
D785325305HA03.25mm Healing Abutment 3.25mm Diameter 5mm Height
D785325303HA03.25mm Healing Abutment 3.25mm Diameter 3mm Height

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.